BACTEC MGIT 960 PZA KIT
FDA 510(k) clearance K021582 · decided 2002-07-13
Clearance details
- K-number
- K021582
- Device name
- BACTEC MGIT 960 PZA KIT
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2002-05-14
- Decision date
- 2002-07-13
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- MJA
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sparks, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VERSATREK MYCO PZA KIT (K052323) | Trek Diagnostic Systems, Inc. | 2006-01-19 |
| BACTEC MGIT 960 SIRE KITS (K014123) | Becton, Dickinson & CO | 2002-04-19 |
| BACTEC MGIT 960 SIR KITS (K003062) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-06-06 |
| ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING (K972772) | Trek Diagnostic Systems, Inc. | 1999-07-13 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycoba recall (Z-2023-2025) | Becton Dickinson & Co. | 2025-06-25 |
| BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycob recall (Z-2686-2024) | Becton Dickinson & Co. | 2024-08-16 |